Cutivate Lotion HPA Axis Pediatric Study
This study has been completed.
Sponsor:
Fougera Pharmaceuticals Inc.
Information provided by:
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00546000
First received: October 16, 2007
Last updated: February 9, 2010
Last verified: December 2008
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Purpose
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Drug: Fluticasone propionate 0.05% lotion |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population |
Resource links provided by NLM:
Further study details as provided by Fougera Pharmaceuticals Inc.:
Primary Outcome Measures:
- Prior and post treatment serum cortisol values will be compared. [ Time Frame: Up to 29 days of treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Record adverse events, skin atrophy, pigmentation change, hematological and chemistry assessments, and changes in atopic dermatitis severity [ Time Frame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 ] [ Designated as safety issue: Yes ]
| Enrollment: | 56 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Receive between 22 and 29 days of Cutivate lotion treatment
|
Drug: Fluticasone propionate 0.05% lotion
Daily applications
|
Eligibility| Ages Eligible for Study: | 3 Months to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects are 3-12 months of age
- Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
- Subjects meet protocol specific AD signs and symptom severity score
Exclusion Criteria:
- Subjects with conditions effecting the HPA Axis
- Subjects with clinically significant systemic disease
- Subjects who require treatment with systemic or topical retinoids during the study
- Subjects who have been treated with various chronic therapies identified in the protocol
- Subjects who have received other investigational drug treatment within 30 days prior to study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546000
Locations
| United States, California | |
| Centre for Health Care Medical Associates | |
| Poway, California, United States, 92064 | |
| Rady Children's Hospital, San Diego | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| University of Miami, Dept. of Dermatology | |
| Miami, Florida, United States, 33125 | |
| United States, Kansas | |
| Adult & Pediatric Dermatology | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Minnesota | |
| Dermatology Center for Children and Young Adults | |
| Eagan, Minnesota, United States, 55121-1176 | |
| United States, Missouri | |
| Central Dermatology | |
| Saint Louis, Missouri, United States, 63117 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Pennsylvania | |
| Paddington Testing Company, Inc | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0783 | |
| University of Texas Health Science Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
| Principal Investigator: | Alan Fleischer Jr., M.D. | Wake Forest University |
| Principal Investigator: | Lawrence F. Eichenfield, MD | Rady Children's Hospital, San Diego |
| Principal Investigator: | Elizabeth Connelly, MD | University of Miami |
| Principal Investigator: | Craig L. Leonardi, MD | Central Dermatology |
| Principal Investigator: | Lawrence Parish, MD | Paddington Testing Company, Inc |
| Principal Investigator: | Adelaide A Hebert, MD | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Sharon Raimer, MD | University of Texas Medical Branch, Galveston |
| Principal Investigator: | Kenneth E. Bloom, MD | Dermatology Center for Children and Young Adults |
| Principal Investigator: | David L Kaplan, MD | Adult & Pediatric Dermatology |
| Principal Investigator: | Stephen W. Shewmake, M.D. | Centre for Health Care Medical Associates |
More Information
No publications provided
| Responsible Party: | Kathleen Ocasio, Manager, Clinical Research Operations |
| ClinicalTrials.gov Identifier: | NCT00546000 History of Changes |
| Other Study ID Numbers: | ALT 0434-01-01 |
| Study First Received: | October 16, 2007 |
| Last Updated: | February 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on October 17, 2012
